80 mg solution for injection in pre-filled pen ixekizumab
What Taltz is and what it is used for
Taltz contains the active substance ixekizumab.
Taltz is intended for the treatment of inflammatory diseases described below:
- Plaque psoriasis in adults
- Plaque psoriasis in children from the age of 6 and adolescents, with a body weight of at least 25 kg
- Psoriatic arthritis in adults
- Radiographic axial spondylitis in adults
- Non-radiographic axial spondylitis in adults.
Ixekizumab belongs to a group of medicines called interleukin inhibitors (IL inhibitors). This medicine works by blocking the activity of a protein called IL-17A, which favors the development of psoriasis and inflammatory diseases of the joints and spine.
Plaque psoriasis
Taltz is used to treat ‘plaque psoriasis in adults and children from the age of 6 and adolescents, weighing at least 25 kg with moderate to severe disease. Taltz can reduce the signs and symptoms of the disease.
If you use Taltz, skin healing is improved and symptoms such as scaling, itching, and pain are reduced.
Psoriatic arthritis
Taltz is used to treat “psoriatic arthritis” in adults, an inflammatory disease of the joints, which often occurs together with psoriasis. If you have psoriatic arthritis, you will first be given other medicines. If you do not respond well enough to these medicines or if you cannot tolerate them, you will be given Taltz to reduce the signs and symptoms of the disease. Taltz can be used alone or with another medicine (called methotrexate).
By using Taltz, you will have fewer signs and symptoms of disease, improved physical function (ability to do normal daily activities), and reduced joint damage.
Axial spondylitis
Taltz is used to treat adults with an inflammatory disease mainly affecting the spine that causes inflammation of the facet joints (spinal joints), called axial spondylitis. If the condition is visible on radiographs, it is called “radiographic axial spondyloarthritis”; if it occurs in patients with no visible signs on radiographs, it is called “non-radiographic axial spondyloarthritis”. If you have axial spondylitis, you will first receive other medicines. If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease and reduce inflammation, and improve your physical function.
What you need to know before you use Taltz
Do not use Taltz
- if you are allergic to ixekizumab or any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor before using Taltz.
- if you have an infection that the doctor considers to be significant (for example, active tuberculosis ).
Warnings and precautions
Talk to your doctor before using Taltz:
- if you have an ongoing infection or if you have had prolonged or repeated infections
- if you have a chronic inflammatory disease of the gastrointestinal tract called Crohn’s disease
- if you have a chronic inflammatory disease of the colon called ulcerative colitis
- if you are receiving any other treatment for psoriasis (eg immunosuppressive agents or treatment with ultraviolet light) or psoriatic arthritis.
Inflammatory bowel disease ( Crohn’s disease or ulcerative colitis )
Stop using Taltz and tell your doctor or seek medical attention immediately if you notice stomach cramps and pain, diarrhea, weight loss, or blood in the stool (possible signs of bowel problems).
If you are not sure if any of the above apply to you, talk to your doctor or nurse before using Taltz.
Be aware of the infection and allergic reactions
Taltz can cause serious side effects, including infection and allergic reactions. You need to be alert for signs of such reactions while using Taltz.
Stop using Taltz and tell your doctor or seek medical help immediately if you develop any signs of a serious infection or allergic reaction. Such signs are listed in the “Serious side effects” list in section 4.
Children and young people
Do not use this medicine to treat plaque psoriasis in children under 6 years of age because it has not been studied in this patient group.
Do not use this medicine to treat psoriatic arthritis in children and adolescents under 18 years of age because it has not been studied in this patient group.
Other medicines and Taltz
Tell your doctor, pharmacist, or nurse
- if you are using, have recently used, or may be using other medicines
- if you have recently been vaccinated or are about to be vaccinated. You should not receive certain types of vaccines while you are using Taltz.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. It is best to avoid using Taltz during pregnancy. The drug’s effect on pregnant women is unknown. If you are female and of childbearing potential, it is recommended that you avoid becoming pregnant and you must use appropriate contraception while using Taltz and for at least 10 weeks after the last dose of Taltz.
If you are breastfeeding or plan to breastfeed, talk to your doctor before using this medicine. You and the doctor should decide whether you can breastfeed or use Taltz. You should not do both.
Driving ability and use of machinery
Taltz is unlikely to affect your ability to drive or use machines.
Taltz contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e. is almost “sodium-free”.
How to use Taltz
Always use this medicine exactly as your doctor or nurse has told you. Consult a doctor, nurse, or pharmacist if you are unsure.
Taltz is given as an injection under the skin ( subcutaneous injection ). You and your doctor or nurse must decide whether you can inject yourself with Taltz.
For children with a body weight between 25 kg and 50 kg, a dose of 40 mg should be used. This must be prepared and given by qualified healthcare personnel.
Use Taltz 80 mg pre-filled injection pen for children who are given an 80 mg dose and therefore do not need dose preparation.
You mustn’t try to give the injections yourself until the doctor or nurse has shown you how to do it. A carer can also give you Taltz injection after training.
Use some form of reminder, write e.g. record the injections in your calendar or diary, so that you do not miss a dose or take a double dose.
Taltz is intended for long-term treatment. The doctor or nurse will check you regularly to see that the treatment is having the desired effect.
Each pen contains one dose of Taltz (80 mg). Each pen delivers only one dose. The pen must not be shaken.
Read the instructions for use of the injection pen carefully before using Taltz.
How much Taltz you should take and for how long
Your doctor will decide how much Taltz you need and for how long.
Plaque psoriasis in adults
- The first dose is 160 mg (two pens with 80 mg in each) given as a subcutaneous injection. This can be given by a doctor or nurse.
- After the first dose, you should take an 80 mg dose (one injection pen ) at weeks 2, 4, 6, 8, 10, and 12. From week 12, you should take an 80 mg dose (one injection pen ) every 4: e weeks.
Plaque psoriasis in children (from the age of 6 and above and with a body weight of at least 25 kg) and adolescents. The recommended dose is given as a subcutaneous injection to children and is based on the following weight categories:
| The child’s body weight | Recommended starting dose (week 0) | Recommended dose every 4 weeks (Q4W) thereafter |
| More than 50 kg | 160 mg (2 pens) | 80 mg (1 pen ) |
| 25 to 50 kg | 80 mg (1 pen ) | 40 mg ( dose needs to be prepared) |
Ixekizumab doses below 40 mg must be prepared and administered from the commercial Taltz 80 mg/1 ml pre-filled syringe by qualified healthcare professionals.
Taltz 80 mg pre-filled pen should be used for children who need a dose of 80 mg and do not need dose preparation. Do not use the Taltz 80 mg pre-filled pen to prepare a 40 mg dose.
Taltz is not recommended for children weighing less than 25 kg.
Psoriatic arthritis
For patients with psoriatic arthritis who also have moderate to severe plaque psoriasis:
- The first dose is 160 mg (two pens with 80 mg in each) given as a subcutaneous injection. This can be given by a doctor or nurse.
- After the first dose, you should take an 80 mg dose (one injection pen ) at weeks 2, 4, 6, 8, 10, and 12. From week 12, you should take an 80 mg dose (one injection pen ) every 4: e weeks.
For other patients with psoriatic arthritis
- The first dose is 160 mg (two injection pens with 80 mg in each) given as a subcutaneous injection. This can be given by a doctor or nurse.
- After the first dose, you should take an 80 mg dose (one injection pen ) every 4 weeks.
Axial spondylitis
- The recommended dose is 160 mg (2 pens with 80 mg in each) given as a subcutaneous injection.
- After the first dose, you should take an 80 mg dose (one injection pen ) every 4 weeks.
If you use too much Taltz
If you have received more Taltz than you should or if you have received a dose too early, tell your doctor.
If you forget to use Taltz
Tell your doctor if you forget to inject a dose of Taltz.
If you stop using Taltz
Do not stop using Taltz without talking to your doctor first. If you stop treatment, your symptoms of psoriasis or psoriatic arthritis may return.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Stop using Taltz and tell your doctor or seek medical help immediately if you experience any of the following side effects. Your doctor will decide if and when you can start the treatment again.
Possible serious infection (may affect up to 1 in 100 people) – signs of this may be:
- fever, flu-like symptoms, night sweats
- tiredness or shortness of breath, cough that does not go away
- hot, reddened, and sore skin, or a painful rash with blisters.
Serious allergic reaction (may affect up to 1 in 1,000 people) – signs of this may be:
- difficulty breathing or swallowing
- low blood pressure, which can cause dizziness or lightheadedness
- swelling of the face, lips, tongue, or throat
- severe itching of the skin, with red rashes or raised nodules.
Other side effects that have been reported
Very common (may affect more than 1 in 10 people):
- upper respiratory tract infections with symptoms such as sore throat and stuffy nose
- injection site reactions (eg skin redness, pain).
Common (may affect up to 1 in 10 people):
- nausea
- fungal infections, e.g. athlete’s foot
- pains in the posterior pharynx
- ulcers in the mouth, skin, and mucous membranes ( herpes simplex, mucocutaneous ).
Uncommon (may affect up to 1 in 100 people):
- thrush (a fungal infection of the mouth)
- influenza
- runny nose
- bacterial infection of the skin
- hives
- watery eyes with itching, redness, and swelling ( conjunctivitis )
- symptoms of lack of white blood cells ( neutropenia ), e.g. fever, sore throat, or mouth ulcers caused by infection er
- low platelet count ( thrombocytopenia )
- eczema
- rash
- rapid swelling of the tissues in the neck, face, mouth, or throat ( angioedema ).
- stomach cramps and pain, diarrhea, weight loss, or blood in the stool (possible signs of bowel problems).
How to store Taltz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the pen label and the outer carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Should not be stored against the back of the refrigerator.
Store in the original packaging. Light sensitive.
Taltz can be stored at room temperature (at a maximum of 30 ºC) for up to 5 days.
Do not use the medicine if the injection pen is damaged or if the medicine is cloudy, distinctly brown, or contains particles.
This medicine is for single use only.
Medicines should not be thrown down the drain. Ask the doctor, nurse, or pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ixekizumab.
A pre-filled pen contains 80 mg of ixekizumab in 1 ml of solution. - Other ingredients are sodium citrate, anhydrous citric acid, sodium chloride, polysorbate 80, and water for injection.
Appearance and package sizes of the medicine
Taltz is a solution in a clear glass syringe. The color can vary from colorless to pale yellow.
The syringe is enclosed in a single-dose pen for single use.
Pack sizes of 1, 2, and 3 pre-filled pens. Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland
Manufacturer
Eli Lilly Italia SpA, Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.